BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
FDA Recall Z-1524-2013 · Posted 2013-06-08
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Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeFZP
Date Initiated2013-04-16
Date Terminated2014-01-30
Product Quantity3,085
Reason for Recall
Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number
combination may have the metal tissue marker separated from the needle prior to use.
Firm Action
Bard Peripheral Vascular, Inc. initiated a recall of certain product code and lot number combinations of Bard UltraClip Dual Trigger Tissue Marker by contacting customers on 04/16/2013. On 04/18/2013, BPV sent a Customer Recall notification Letter via FedEx with proof of delivery notice. The letter included reason for recall, a table of affected product code and lot numbers, instructions (Do not use or further distribute any affected product), a response form (titled Recall and Effectiveness Check Form) enclosed, and contact information.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution: USA Nationwide and Internationally to Europe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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